PLAVIX SUMMARY
PLAVIX®
clopidogrel bisulfate tablets
PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic events as follows:
- Recent MI, Recent Stroke or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
- Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
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PLAVIX NEWS HIGHLIGHTS Media Articles Related to Plavix (Clopidogrel)
Plavix Plus Aspirin Lowers Stroke Risk
Source: MedicineNet clopidogrel Specialty [2009.04.01]
Title: Plavix Plus Aspirin Lowers Stroke Risk
Category: Health News
Created: 4/1/2009 2:00:00 AM
Last Editorial Review: 4/1/2009
Plavix Plus Heartburn Drugs May Hike Heart Risk
Source: MedicineNet lansoprazole Specialty [2009.01.29]
Title: Plavix Plus Heartburn Drugs May Hike Heart Risk
Category: Health News
Created: 1/29/2009 2:00:00 AM
Last Editorial Review: 1/29/2009
Secondary Prevention: Aspirin Combined With Dipyridamole Just As Effective As Clopidogrel; Endarterectomy Safer Than Angioplasty
Source: Stroke News From Medical News Today [2009.06.23]
In the area of secondary prevention as well - guarding against renewed events in patients who already suffered from a stroke or a TIA - Professor Ferro points to important new research: "In this patient population, the direct comparison between Clopidogrel and the combination of aspirin with extended release Dipyridamole did not reveal any difference between both strategies." Both approaches have proven to be slightly more effective than aspirin alone.
Published Studies Related to Plavix (Clopidogrel)
Tailored clopidogrel loading dose according to platelet reactivity monitoring to prevent acute and subacute stent thrombosis. [2009.01.01]
Stent thrombosis remains a significant pitfall of percutaneous coronary intervention (PCI)... In conclusion, a tailored clopidogrel [generic for Plavix] LD according to platelet reactivity monitoring decreases the rate of early stent thrombosis after PCI without increasing bleeding.
Randomized trial comparing 600- with 300-mg loading dose of clopidogrel in patients with non-ST elevation acute coronary syndrome undergoing percutaneous coronary intervention: results of the Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increment after Coronary intervention in Acute coronary Lesions (PRACTICAL) Trial. [2009.01]
BACKGROUND: There is uncertainty about the benefit of a higher loading dose (LD) of clopidogrel [generic for Plavix] in patients with non-ST elevation acute coronary syndrome (NSTEACS) undergoing early percutaneous coronary intervention (PCI)... CONCLUSIONS: These data confirm a modest incremental antiplatelet effect of a 600-mg clopidogrel LD compared with 300-mg LD but provide no support for a clinical benefit in patients with NSTEACS managed with an early invasive strategy including a high rate (69%) of glycoprotein IIb/IIIa inhibitor use during PCI.
A double-blind placebo-controlled investigation of the psychomotor profile of clopidogrel in healthy volunteers. [2008.12]
Clopidogrel [generic for Plavix] is a thienopyridine antiplatelet agent that inhibits adenosine diphosphate-dependent platelet activation and aggregation and is currently one of the most widely prescribed antiplatelet drugs for the treatment of symptomatic coronary artery disease.In this study, we found that single oral doses of clopidogrel in our group of normal healthy volunteers did not affect their psychomotor performance.
Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. [2008.12]
BACKGROUND: Antiplatelet therapy with clopidogrel [generic for Plavix] and acetylsalicylic acid (ASA) reduces major cardiovascular events in patients with ST and non-ST-segment-elevation acute coronary syndromes (ACS). Recent mechanistic and clinical data suggest that higher loading and maintenance doses of clopidogrel may achieve a more rapid and greater degree of platelet inhibition that translates into improved clinical outcomes, but this is yet to be formally evaluated in an adequately powered randomized trial. OBJECTIVES: To evaluate the efficacy and safety of (1) a higher loading and initial maintenance dose of clopidogrel compared with the standard-dose regimen and (2) high-dose ASA compared with low-dose ASA in patients with ST or non-ST-segment-elevation ACS managed with an early invasive strategy... CONCLUSIONS: The CURRENT-OASIS 7 trial will help to define optimal dosing regimens for clopidogrel and ASA in patients with ST and non-ST-segment-elevation ACS treated with an early invasive strategy.
Aprotinin for patients exposed to clopidogrel before off-pump coronary bypass. [2008.12]
To verify whether low-dose aprotinin reduces blood loss and blood product usage in patients with clopidogrel [generic for Plavix] exposure within 5 days before off-pump coronary artery bypass, 51 patients with clopidogrel exposure were randomized in a double-blind fashion to receive low-dose aprotinin (25 patients), or placebo (26 patients)... In patients with unstable angina and recent clopidogrel exposure who are undergoing off-pump coronary artery bypass, intraoperative administration of low-dose aprotinin is recommended to reduce blood loss and transfusion requirements.
Clinical Trials Related to Plavix (Clopidogrel)
Pharmacodynamics of CGT 2168 Compared With Plavix® [Active, not recruiting]
CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to
characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose
combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®
(clopidogrel, 75 mg).
Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,
subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®
in the order determined by the randomization schedule. Each period of dose administration
will be separated by a two-week washout period. Study exit will occur 1 week after Dosing
Period 2. The expected total duration of participation is 8 weeks (56 days), including a
screening visit on or within 21 days prior to enrollment.
On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the
Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected
pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent
and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and
pre-dose and serially after dosing on Day 7.
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function [Completed]
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces
peri-procedural and long-term ischemic complications. Documented reduced response to
clopidogrel has been associated with subsequent major adverse cardiovascular events.
Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing
regimens of clopidogrel given before elective PCI.
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS [Completed]
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in
patients with coronary artery disease. In the proposed study we wish to prospectively assess
the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with
clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients
who demonstrate non-responsiveness to clopidogrel.
Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.
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